A new bill aims to clarify the rules of the Controlled Substances Act to ensure that legitimate operators stay in business and patients get needed medication, according to congressional backers of the bill, which was approved by the House of Representatives on July 29.
The bill still has to be taken up by the Senate, where there is no companion legislation.
The Ensuring Patient Access and Effective Drug Enforcement Act of 2014 (H.R. 4709) would ensure that restrictions on distribution of controlled substances are not so onerous as to inhibit access for patients, would require the U.S. Attorney General to give DEA registrant pharmacies and physicians who violate the rules an opportunity to submit a corrective action plan that might defer suspension of their registration, and would establish a working group to make recommendations to Congress on federal policies to reduce prescription drug diversion and abuse.
These measures are among the major policy goals of the Alliance to Prevent the Abuse of Medicines. The Washington, D.C.–based group includes among its members the American Medical Association, Cardinal Health, CVS Caremark, the Health Industry Distributors Association, and Teva.
The National Association of Chain Drug Stores "and chain pharmacy are committed to partnering with federal and state agencies, law enforcement personnel, policymakers, and other stakeholders to work on viable strategies to simultaneously advance patient health and prevent prescription drug abuse," NACDS President and CEO Steven C. Anderson, said in a statement regarding the bill.
Rep. Marsha Blackburn (R-Tenn.), a cosponsor of the bill, said in a statement that simply acknowledging the epidemic of prescription drug abuse isn’t enough. "Congress has a responsibility to make sure the law is crystal clear for both the DEA and legitimate businesses who want to understand what the rules are so they can do the right thing."
In House testimony last April, DEA Deputy Assistant Administrator Joseph Rannazzisi said the agency’s job is getting tougher. The number of registrants that the DEA regulates has mushroomed from 480,000 in 1973 to 1.5 million today, he said. At the same time, diversion and abuse have risen steeply, with opioids selling on the black market for 5-10 times their retail value.
In the last 3 years, the DEA’s Tactical Diversion Squads have increased from 37 to 66, and the agency has been applying its stiffest penalty – an immediate suspension order – in a judicious manner, according to Mr. Rannazzisi. From October 2013 through March 2014, 20 suspensions were ordered.
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